The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Pressure Catheter Placement Set 50010.
| Device ID | K841482 |
| 510k Number | K841482 |
| Device Name: | PRESSURE CATHETER PLACEMENT SET 50010 |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | DLP, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-09 |
| Decision Date | 1984-06-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994654069 | K841482 | 000 |
| 20613994679745 | K841482 | 000 |
| 20613994679738 | K841482 | 000 |
| 20613994654056 | K841482 | 000 |